Isoniazid Injection

Name: Isoniazid Injection

What are some things I need to know or do while I take Isoniazid Injection?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Talk with your doctor before you drink alcohol.
  • Take vitamin B6 (pyridoxine) as you were told by your doctor.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Have an eye exam as you have been told by your doctor.
  • Some foods and drinks like cheese and red wine, when taken with isoniazid injection, may cause very risky effects such as sudden high blood pressure. To avoid these problems, get a list of foods to avoid.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
  • A very bad and sometimes deadly reaction has happened with isoniazid injection. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Isoniazid Injection) best taken?

Use isoniazid injection as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • To gain the most benefit, do not miss doses.
  • It is given as a shot into a muscle.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

How do I store and/or throw out Isoniazid Injection?

  • If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Adverse Reactions

The most frequent reactions are those affecting the nervous system and the liver.

Nervous system: Peripheral neuropathy is the most common toxic effect. It is dose related, occurs most often in the malnourished and in those predisposed to neuritis (e.g., alcoholics and diabetics), and is usually preceded by paresthesias of the feet and hands. The incidence is higher in slow acetylators.

Other neurotoxic effects which are uncommon with conventional doses are convulsions, toxic encephalopathy, optic neuritis and atrophy, memory impairment, and toxic psychosis.

Gastrointestinal: Nausea, vomiting, and epigastric distress.

Hepatic: See boxed WARNING. Elevated serum transaminases (SGOT; SGPT), bilirubinemia, bilirubinuria, jaundice, and occasionally severe and sometimes fatal hepatitis. The common prodromal symptoms of hepatitis are anorexia, nausea, vomiting, fatigue, malaise, and weakness. Mild hepatic dysfunction, evidenced by mild and transient elevation of serum transaminase levels occurs in 10 to 20 percent of patients taking isoniazid. This abnormality usually appears in the first 1 to 3 months of treatment but can occur at any time during therapy. In most instances, enzyme levels return to normal, and generally, there is no necessity to discontinue medication during the period of mild serum transaminase elevation. In occasional instances, progressive liver damage occurs, with accompanying symptoms. If the SGOT value exceeds three to five times the upper limit of normal, discontinuation of the isoniazid should be strongly considered. The frequency of progressive liver damage increases with age. It is rare in persons under 20, but occurs in up to 2.3 percent of those over 50 years of age.

Hematologic: Agranulocytosis; hemolytic, sideroblastic, or aplastic anemia; thrombocytopenia; and eosinophilia.

Hypersensitivity: Fever, skin eruptions (morbilliform, maculopapular, purpuric, or exfoliative), lymphadenopathy, and vasculitis.

Metabolic and endocrine: Pyridoxine deficiency, pellagra, hyperglycemia, metabolic acidosis, and gynecomastia.

Miscellaneous: Rheumatic syndrome and systemic lupus erythematosus-like syndrome. Local irritation has been observed at the site of intramuscular injection.

Isoniazid Injection Dosage and Administration

(See also INDICATIONS)

NOTE: For preventive therapy of tuberculous infection and treatment of tuberculosis, it is recommended that physicians be familiar with the following publications: (1) the recommendations of the Advisory Council for the Elimination of Tuberculosis, published in the MMWR: vol 42; RR-4, 1993 and (2) Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children, American Journal of Respiratory and Critical Care Medicine: vol 149; 1359-1374, 1994.

Isoniazid Injection USP is used in conjunction with other effective antituberculous agents.

For Treatment of Tuberculosis

Drug susceptibility testing should be performed on the organism initially isolated from all patients with newly diagnosed tuberculosis. If the bacilli becomes resistant, therapy must be changed to agents to which the bacilli are susceptible.

Usual Parenteral Dosage (Depending On the Regiman Used)

Adults

5 mg/kg up to 300 mg daily in a single dose; or 15 mg/kg up to 900 mg/day, two or three times/week

Children:

10 to 15 mg/kg up to 300 mg daily in a single dose; or 20 to 40 mg/kg up to 900 mg/day, two or three times/week

Patients with Pulmonary Tuberculosis Without HIV Infection

There are three regimen options for the initial treatment of tuberculosis in children and adults:

Option 1: Daily isoniazid, rifampin, and pyrazinamide for 8 weeks followed by 16 weeks of isoniazid and rifampin daily or 2 to 3 times weekly.

Ethambutol or streptomycin should be added to the initial regimen until sensitivity to isoniazid and rifampin is demonstrated. The addition of a fourth drug is optional if the relative prevalence of isoniazid-resistant Mycobacterium tuberculosis isolates in the community is less than or equal to four percent.

Option 2: Daily isoniazid, rifampin, pyrazinamide and streptomycin or ethambutol for 2 weeks followed by twice weekly administration of the same drugs for 6 weeks, subsequently twice weekly isoniazid and rifampin for 16 weeks.

Option 3: Three times weekly with isoniazid, rifampin, pyrazinamide and ethambutol or streptomycin for 6 months.

*All regimens given twice weekly or 3 times weekly should be administered by directly observed therapy (see also Directly Observed Therapy).

The above treatment guidelines apply only when the disease is caused by organisms that are susceptible to the standard antituberculous agents. Because of the impact of resistance to isoniazid and rifampin on the response to therapy, it is essential that physicians initiating therapy for tuberculosis be familiar with the prevalence of drug resistance in their communities. It is suggested that ethambutol not be used in children whose vital acuity cannot be monitored.

Patients with Pulmonary Tuberculosis and HIV Infection

The response of the immunologically impaired host to treatment may not be satisfactory as that of a person with normal host responsiveness.

For this reason, therapeutic decisions for the impaired host must be individualized. Since patients co-infected with HIV may have problems with malabsorption, screening of antimycobacterial drug levels, especially in patients with advanced HIV disease, may be necessary to prevent the emergence of MDRTB.

Patients with Extra Pulmonary Tuberculosis

The basic principles that underlie the treatment of pulmonary tuberculosis also apply to Extra pulmonary forms of the disease. Although there have not been the same kinds of carefully conducted controlled trials of treatment of Extra pulmonary tuberculosis as for pulmonary disease, increasing clinical experience indicates that a 6 to 9 month short-course regimens are effective. Because of the insufficient data, miliary tuberculosis, bone/joint tuberculosis, and tuberculosis meningitis in infants and children should receive 12 month therapy.

Bacteriologic evaluation of Extra pulmonary tuberculosis may be limited by the relative inaccessibility of the sites of disease. Thus, response to treatment often must be judged on the basis of clinical and radiographic findings.

The use of adjunctive therapies such as surgery and corticosteroids is more commonly required in Extra pulmonary tuberculosis than in pulmonary disease. Surgery may be necessary to obtain specimens for diagnosis and to treat such processes as constrictive pericarditis and spinal cord compression from Potts Disease. Corticosteroids have been shown to be of benefit in preventing cardiac constriction from tuberculous pericarditis and in decreasing the neurologic sequelae of all stages of tuberculosis meningitis, especially when administered early in the course of the disease.

Pregnant Women with Tuberculosis

The options listed above must be adjusted for the pregnant patient. Streptomycin interferes with in utero development of the ear and may cause congenital deafness. Routine use of pyrazinamide is also not recommended in pregnancy because of inadequate teratogenicity data. The initial treatment regimen should consist of isoniazid and rifampin. Ethambutol should be included unless primary isoniazid resistance is unlikely (isoniazid resistance rate documented to be less than 4%).

Treatment of Patients with Multi-Drug Resistant Tuberculosis (MDRTB)

Multiple-drug resistant tuberculosis (i.e., resistance to at least isoniazid and rifampin) presents difficult treatment problems. Treatment must be individualized and based on susceptibility studies. In such cases, consultation with an expert in tuberculosis is recommended.

Directly Observed Therapy (DOT)

A major cause of drug-resistant tuberculosis is patient non-compliance with treatment. The use of DOT can help assure patient compliance with drug therapy. DOT is the observation of the patient by a health care provider or other responsible person as the patient ingests antituberculosis medications. DOT can be achieved with daily, twice weekly or thrice weekly regimens, and is recommended for all patients.

For Preventative Therapy of Tuberculosis

Before isoniazid preventive therapy is initiated, bacteriologically positive or radiographically progressive tuberculosis must be excluded. Appropriate evaluations should be performed if Extra pulmonary tuberculosis is suspected.

Adults over 30 Kg: 300 mg per day in a single dose.

Infants and Children: 10 mg/kg (up to 300 mg daily) in a single dose.

In situations where adherence with daily preventative therapy cannot be assured, 20 to 30 mg/kg (not to exceed 900 mg) twice weekly under the direct observation of a health care worker at the time of administration8.

Continuous administration of isoniazid for a sufficient period of time is an essential part of the regimen because relapse rates are higher if chemotherapy is stopped prematurely. In the treatment of tuberculosis, resistant organisms may multiply and the emergence during the treatment may necessitate a change in the regimen.

For following patient compliance: the Potts-Cozart test9, a simple colorimetric6 method of checking for isoniazid in the urine, is a useful tool for assuring patient compliance, which is essential for effective tuberculosis control. Additionally, isoniazid test strips are also available to check patient compliance.

Concomitant administration of pyridoxine (B6) is recommended in the malnourished and in those predisposed to neuropathy (e.g., alcoholics and diabetics).

How is Isoniazid Injection Supplied

Isoniazid Injection USP is available for intramuscular use in 10 mL vials providing 100 mg isoniazid per mL NDC 0781-3056-70.

Storage

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from light.

Isoniazid Injection USP may crystallize at low temperatures. If this occurs, warm the vial to room temperature before use to redissolve the crystals.

References

1. Murphy, R. et al: Annuals of Internal Medicine; 1990: November 15; volume 113:799-800. 2. Burke, R.F., et al: Res Commun Chem Pathol Pharmacol.1990; July; vol. 69; 115-118. 3. Fleenor, M.F., et al: Chest (United States) Letter,; 1991: June;99 (6):1554. 4. Baciewicz, A.M. and Baciewicz, Jr. F.A.,: Arch Int Med 1993, September; volume 153; 1970-1971. 5. Jonville, A.P., et al: European Journal of Clinical Pharmacol (Germany), 1991:40 (2) p198. 6. American Thoracic Society/Centers for Disease Control: Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children. Amer. J. Respir Crit Care Med. 1994; 149: p1359-1374. 7. Hoglund P., et al: European Journal of Respir Dis (Denmark) 1987: February; 70 (2) p110-116. 8. Committee on infectious Diseases American Academy of Pediatrics: 1994, Red Book: Report of the Committee on Infectious Diseases; 23 edition; p487. 9. Schraufnagel, DE; Testing for Isoniazid; Chest (United States) 1990, August: 98 (2) p314-316.

03-2009M

U1006841

Manufactured in Canada by

Sandoz Canada Inc. for

Sandoz Inc., Princeton, NJ 08540

Uses

Consult your pharmacist.

How to use Isoniazid Vial

Consult your pharmacist.

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